QC Analyst – MicroBiology

• Carrying out In-Process testing of critical lot related samples to support Manufacturing activities.

• Performing Bioburden testing on Utility samples, Drug Substance and Raw Materials within required hold times.

• Performing Bacterial Endotoxin Testing on Utility samples, Drug Substance and Drug Product within required hold times.

• Performing Growth Promotion testing of media lots entering the laboratory.

• Carrying out identifications of Microorganisms isolated post testing activities.

• Carrying out the Minute Mouse Virus by PCR for in-process samples.

• Performing compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples in accordance with applicable procedures and cGMP requirements.

• Completing all laboratory documentation in a timely and accurate manner.

• Compliance with Standard Operating Procedures and Registered Specifications.

• Assisting in authoring and reviewing documentation.

• Providing support to other departments to ensure qualification and production schedules are adhered to.

• Reviewing paperwork, and reconciliation of analysis performed in the laboratory.

• Ensuring that any alert/action limit excursions are investigated according to site procedures.

• Adherence to and improvement upon lean lab and 6S practices.

• Ensuring a high standard of housekeeping and safety is maintained in the laboratory.

• Performing any other activities as indicated by the Microbiology Manager.

Qualification, Knowledge and Experience

• The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.

• At least 1 years' experience in a pharmaceutical / healthcare laboratory or related technical function.

• A strong background in Microbiology and aseptic technique is desirable but not essential.

• Sterility experience is desirable but not essential.

• Experience in Bioburden and Endotoxin testing is desirable but not essential.

• Experience using MODA, CIMS, LIMS, LES and Veeva Vault is desirable but not essential.

• The successful candidate must demonstrate excellent written and verbal communication skills.

• The ability to work in a team based collaborative environment is essential.

Note: This candidate may be required to work a shift pattern.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Why you should apply

• You will help patients in their fight against serious diseases

• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.

• You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to on-site gym and life assurance.

Seniority level

• Seniority levelEntry level

Employment type

• Employment typeContract

Job function

• Job functionQuality Assurance
• IndustriesPharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care

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